Enrolment has been completed in the TRANSFORM II randomised controlled trial, comparing the MagicTouch (Concept Medical) sirolimus drug-coated balloon (DCB) to an everolimus drug-eluting stent (DES) in treating de-novo coronary lesions.
TRANSFORM II is an investigator-initiated trial sponsored by Fondazione Ricerca e Innovazione Cardiovascolare (RIC) in Milan, Italy, taking place in 52 centres across Europe, Asia and South America. A total of 1,832 patients with de novo coronary lesions (vessel diameter >2mm to ≤3.5mm; lesion length ≤50 mm) have been enrolled in the study, with follow-up to be conducted out to five years. The trial has a primary endpoint of target lesion failure at 12 months, with an optical coherence tomography (OCT) imaging sub-study to assess angiographic outcomes in 70 patients taking place at nine months.
Commenting on the enrolment milestone, TRANSFORM II, study chairman Bernardo Cortese (Fondazione RIC and Harrington Heart & Vascular Institute UH, Cleveland, USA), said: “After three-and-a-half years we were able to complete the enrolment in the TRANSFORM II trial, a study that involved 52 centres across three continents, and this is amazing. The effort put in by our team at Fondazione RIC and each investigator of the study led to quite a fast enrolment in such a big, ambitious study.
“Our goal is to advance the adoption of DCBs in the coronary space, testing this sirolimus DCB with the most studied and used DES, in a daily patient population. Along with the guidance of the recently published DCB ARC guidelines, we are paving the route for the modern angioplasty era.”
DCB technology has been seen as a promising solution for small, de novo coronary lesions, and sirolimus is a viable alternative to the first generation of DCBs eluting paclitaxel.
Manish Doshi, founder and managing director of Concept Medical, said: “The completion of patient enrolment in TRANSFORM II is a significant milestone in our mission to bring innovative drug-delivery technologies to the forefront of interventional cardiology. We are proud to scientifically support one of the largest global randomised trials evaluating sirolimus-coated balloon technology. This achievement reflects our commitment to clinical excellence, scientific rigour, and ultimately, better outcomes for patients around the world.”
